气相色谱法测定一种氨基醇盐酸盐中的有关物质  

Determination of Related Substances in an Amino Alcohol Hydrochloride by Gas Chromatography

作　　者：龚爱琴[1] 刘明艳 王雅静 金党琴[1] CONG Ai-qin;LIU Ming-yan;WANG Ya-jing;Jin Dang-qin(Yangzhou Polytechnic Institute,Yangzhou 225127,China;Jiangsu Aidi Pharmaceutical Co.,Ltd,Yangzhou 225127,China)

机构地区：[1]扬州工业职业技术学院,江苏扬州225127 [2]江苏艾迪药业股份有限公司,江苏扬州225127

出　　处：《化学研究与应用》2025年第2期495-499,共5页Chemical Research and Application

基　　金：江苏省教学名师项目(苏教师函[2023]30号)资助;江苏省高等学校基础科学(自然科学)研究重大项目(22KJA150009)资助;扬州市科技公共服务平台项目(YZ2022150)资助。

摘　　要：本文建立了一种气相色谱法检测整合酶抑制剂1类新药生产中使用的关键物料氨基醇盐酸盐中的有关物质的方法。以氮气为载气,用氢火焰离子化检测器(FID)检测,色谱柱为SH-I-1 MS毛细管色谱柱(60 m×0.25 mm×1.0μm),柱温为程序升温,氨基醇盐酸盐中的有关物质与氨基醇盐酸盐及相互之间能很好地分离,线性关系实验表明3个已知杂质在相应的浓度范围内(约37.0~370.0μg·mL^(-1))峰面积与浓度呈良好的线性关系,稳定性实验表明溶液在24 h内测定结果基本一致(RSD均小于3.0%),耐用性实验表明测定条件稍有变化对测定结果影响不大(RSD小于1.0%)。To establish a gas chromatography method for determination of relevant substances in key material amino alcohol hydrochloride used in the production of class 1 new drugs for integrase inhibitors,SH-I-1 MS capllary column(60 m×0.25 mm x1.0μm)with nitrogen gas as carrier and FID as detector was applied.The relevant substances was tested under a gradient temperature.The related substances in amino alcohol hydrochloride can be well separated from amino alcohol hydrochloride and from each other.The linear relationship experiment showed that there is a good linear relationship between the peak area and concentration of three known impurities within the corresponding concentration range(about 37.0~370.0μg·mL^(-1)).The stability experiment showed that the solution was basically stable within 24 hours(RSD was less than 3.0%).The durability experiment pointed out that slight changes in measurement conditions have little effect on the measurement results(RSD less than 1.0%).

关 键 词：氨基醇盐酸盐 整合酶抑制剂 气相色谱法 含量测定 

分 类 号：O623.4[理学—有机化学]